Phase 3
N=2,235
Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00306527 ↗Enrolled (actual)
2,235
Serious AEs
2.9%
Results posted
Jan 2013
Primary outcome: Primary: Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine — 78; 73; 47; 51 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cell culture derived influenza vaccine (Biological); egg-derived influenza subunit vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Dec 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine |
78; 73; 47; 51; 76; 84 | — |
| SECONDARY Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine |
50; 38; 70; 58; 35; 44 | — |
| SECONDARY Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects |
40; 34; 26; 20; 35; 36 | — |
| SECONDARY Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects |
2.14; 2.46; 2.2; 2.98; 2.02; 2.91 | — |
| SECONDARY Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. |
57; 48; 49; 36; 54; 57 | — |
| SECONDARY Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. |
22; 32; 30; 34; 24; 30 | — |
Summary
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.
Eligibility Criteria
Inclusion Criteria
- 18 to < 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
- Mentally competent to understand the nature, the scope and the consequences of the study
- Able and willing to give written informed consent prior to study entry
- Available for all the visits scheduled in the study
- in good health as determined by:
- Medical history related to the previous six months,
- Physical examination,
- Clinical judgment of the investigator.
Exclusion Criteria
- Unwilling or unable to give written informed consent to participate in the study
- Currently experiencing an acute infectious disease
- Any serious disease such as, for example:
- Cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy)
- Autoimmune disease (including rheumatoid arthritis)
- Advanced arteriosclerotic disease or complicated diabetes mellitus
- Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy
- Acute or progressive hepatic disease
- Acute or progressive renal disease
- Congestive heart failure
- Surgery planned during the study period
- Bleeding diathesis
- History of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Known or suspected impairment/alteration of immune function resulting from:
- Receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy)
- Receipt of immunostimulants
- Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study
- High risk for developing an immunocompromising disease
- History of drug or alcohol abuse
- Laboratory confirmed influenza disease in the past 6 months
- Received influenza vaccine within the past 6 months
- Received another vaccine or any investigational agent within the past 60 days, or expect to receive another vaccine within 3 weeks following the study vaccination
- Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study
- Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever \_ 38°C within the past 5 days
- Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Data sourced from ClinicalTrials.gov (NCT00306527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.